Director, Facilities Maintenance & Operations

Ultragenyx Pharmaceutical•Bedford, MA

19h•$1 - $2•Onsite

About The Position

ultra innovative – Tackle rare and dynamic challenges The Director of Facilities Maintenance & Operations is a leadership role responsible for strategic oversight and operational excellence of all maintenance operations functions within a highly regulated biopharmaceutical manufacturing facility and GMP QC testing lab. This role ensures the reliability, availability, and compliance of equipment, utilities, facilities, and related systems to support drug substance and drug product manufacturing in accordance with industry quality and safety standards. The Director drives continuous improvement, leads cross-functional initiatives, and serves as the site’s key technical interface during regulatory inspections and presentations. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Requirements

Bachelor of Science (B.S.) degree in Mechanical Engineering, Electrical Engineering, or a closely related engineering discipline
15+ years of progressive experience in maintenance engineering or reliability functions within biopharmaceutical, pharmaceutical, or other highly regulated manufacturing environments.
Leadership experience with roles in engineering and maintenance teams and functions.
Demonstrated experience presenting to, and interacting with, regulatory agencies (FDA, EMA or equivalent).
Deep familiarity with GMP compliance, clean utilities (e.g., HVAC, WFI, compressed gases), cleanrooms, sterile manufacturing processes, critical manufacturing equipment, and facility infrastructure.
Proven track record in implementing maintenance management systems (CMMS), reliability strategies, and continuous improvement initiatives
Experience supporting deviation investigations, root cause analysis, and CAPA implementation
Ability to read and interpret technical drawings, equipment manuals, and engineering specifications
Strong organizational skills and attention to detail in a fast-paced, compliance-driven environment
Comprehensive knowledge of 21 CFR Part 210/211, EU GMP Annex 1, OSHA, and relevant environmental regulations.
Strong analytical, problem-solving, and decision-making skills with a reliability engineering mindset.
Excellent communication skills with the ability to influence at all organizational levels.
Experience with budget oversight, project prioritization, risk management, and cross-functional leadership.
Proficient in industry best practices including Lean, Six Sigma, and risk-based equipment management.

Responsibilities

Strategic Leadership & Management Provide vision, leadership, and strategic direction for facilities maintenance & operations teams.
Build and develop high-performing maintenance and calibration teams; recruit, mentor, and retain top talent.
Develop departmental goals, KPIs, and performance metrics aligned with corporate objectives and operational needs.
Champion reliability-centered maintenance (RCM), predictive and preventive maintenance strategies, and best-in-class maintenance engineering practices seen commonly in biopharmaceutical and highly regulated manufacturing environments.
Maintenance & Reliability Engineering Work with Engineering for the effective execution and continuous improvement of preventive and predictive maintenance programs to ensure optimal asset performance and minimal unplanned downtime.
Support lifecycle management of critical plant and process equipment including qualification, calibration strategies, and validation support.
Partner with engineering, operations, quality, and validation teams to embed risk-based maintenance planning into lifecycle activities.
Regulatory Compliance & Safety Ensure all maintenance and calibration activities are compliant with FDA 21 CFR Part 210/211, EU GMP Annex 1, OSHA, EPA, and other applicable regulatory, safety and environmental standards.
Maintain audit-ready documentation and defend maintenance and calibration systems during regulatory inspections Lead presentations and technical discussions with regulatory bodies and support responses to audit findings, deviations, and CAPAs.
Promote a culture of safety, ensuring adherence to health, safety, environmental and GMP requirements throughout maintenance work.
Capital Projects & Budget Management Participate in long-range facility and equipment capital planning; identify necessary capital projects, upgrades, and equipment installations for facilities and utilities.
Prepare and manage departmental operating and capital budgets; optimize cost, quality, and service delivery.
Collaborate with cross-functional teams (manufacturing, quality, project management, validation) to align maintenance engineering projects with business and compliance goals.
Cross-Functional Collaboration & Communication Act as the primary maintenance operations representative to site leadership and stakeholders.
Provide regular reports to senior leadership on reliability, maintenance performance, risks, and improvement initiatives.
Cultivate partnerships with external vendors, original equipment manufacturers, and service providers to maintain high levels of technical expertise and service